Postoperative Lymphedema Treatment in Upper Extremities Following Axillary Lymphadenectomy by Transplanting Autologous Endothelial Progenitor Cells (EPC)
The procedure will be as follows:
10 patients were recruited in the General Surgery or Oncology meeting the inclusion
criteria. During the study, patients can´t use any other kind of treatment for the
Visit 1: We explain the procedure by inviting patients to participate after signing informed
consent. There will be a complete medical history, review of inclusion and exclusion
criteria, signing a letter of informed consent, be requested general laboratory tests (blood
count, biochemical profile), tele-ray.
Visit 2: Initiation colony stimulating factor (Filgrastim SC) to 300 micrograms per day for
3 consecutive days.
Visit 3: Conduct a puncture and bone marrow harvesting under local anesthesia of the
posterior iliac crest with Jamshidi needle to aspirate (approximately 50 - 100ml). The
product obtained will be centrifuged in a refrigerated centrifuge at 3500 Sigma EK15 ®
rpm/15 minutes to 8 ° C with HES 6% (pentastarch 6g/100ml) to obtain the mononuclear cell
layer. Once the cells were obtained will be transported to the operating room to manage the
patient by intramuscular injection of 0.5 to 1 ml in 30 to 50 sites of the affected limb
with a depth of about one centimeter, using a needle number 25. The administration will take
place in the operating room under local anesthesia or sedation if necessary.
Visit 4 and subsequent: clinical evaluation will be conducted each week, especially data
monitoring of infection in the puncture sites. At week 12 post-cell infusion, the latest
revision will be made and carried out measurements in both arms to conclude and determine
the outcome of treatment.
Phase 2 (Control group):
Another 10 patients with lymphedema will be included in a 6 week study to compare the most
common treatment of the lymphedema, the compressed sleeves.
Visit 1: A complete medical history will be performed. A compression sleeve will be given to
the patients for their use during the next 2 weeks.
Visit 2 and 3: On week 2 and 3 of the compression sleeve treatment, the patients will be
measured in both upper extremities as well as assess the symptoms or not that patients
Visit 4 and 5: Patients will stop using the compression sleeve treatment for the next 2
weeks measured both upper extremities and interrogate patients about symptoms during this
Visit 6 and 7: The last 2 weeks of the study patients will be asked to restart the
compressed sleeves treatment and measured both upper extremities and interrogate patients
about symptoms presented during this stage of the study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine if the stem cells are effective in patients with lymphedema with the decreased of the volume of the affected limb and improvement of the symptomatology.
Patients will be measured in 4 different areas of both arms with a tape measure, before the transplant and weekly after the transplant for 3 months. Measure 1: 10 cm over the epicondyle. Measure 2: 5 cm over the the epicondyle. Measure 3: 5 cm under the the epicondyle. Measure 4: 15 cm under the the epicondyle Also a questionnaire of the most common symptoms will be given to the patients to mark their own symptoms before the transplant and 3 months after the transplant.
Gerardo E. Muñoz Maldonado, MD
Hospital Universitario Dr Jose Eleuterio Gonzalez
Mexico: Ethics Committee